| Eligibility |
Inclusion Criteria:
• The diagnostic criteria of the American diabetes Association (ADA) were used to determine
the type of subjects: Group Healthy individuals: Glycated hemoglobin (HbA1c) = 5.6%; Group
Pre T2DM patients: 5.7% = HbA1c = 6.4%; Group T2DM patients: HbA1c = 6.5% (for T2DM
patients: this study needs to include first-time or previously diagnosed patients who have
not used hypoglycemic drugs within 4 years and HBA1C = 9.5%)Clinical diagnosis of
Alzheimer's Disease.
- Male weight = 50kg, female weight = 45kg, 18.5 < BMI < 24kg/m2
- Age range from 40 years old (inclusive) to 65 years old (inclusive), with no less than
one-third of either gender
- Subjects voluntarily sign informed consent forms, can maintain good communication with
researchers, and comply with the requirements of clinical trials
Exclusion Criteria:
- In the past month and currently taking glucocorticoids, steroids, thiazide diuretics,
or atypical antipsychotic drugs
- Some diseases that affect glucose tolerance: type 1 diabetes (T1DM), pancreatic
exocrine disease, polycystic ovary syndrome and other endocrine diseases, autoimmune
diseases, infection and trauma and other irritability factors
- Diseases that may affect eating: mental illness, post gastrectomy, inflammatory bowel
disease, uncontrolled thyroid disease.
- Healthy subjects with a history of gestational diabetes or subjects with direct family
members with a family history of diabetes
- Pregnant or lactating women
- Participate in any other clinical trials within 3 months prior to the trial
- Blood donation or loss of = 400mL within 8 weeks before the first cycle of the
experiment
- Clinically significant history of ECG abnormalities or family history of long QT
syndrome (grandparents, parents, siblings) Suffering from any condition that
significantly affects glucose absorption, distribution, metabolism, and excretion
within 2 weeks prior to the experiment, or any condition that may pose a hazard to the
subject, the detailed conditions are as follows:
1. History of inflammatory bowel disease, gastritis, ulcers, gastrointestinal or
rectal bleeding
2. A significant history of gastrointestinal surgery (such as gastrectomy,
gastroenterostomy, or intestinal resection),
3. history of pancreatic injury or pancreatitis or clinical evidence, or
researchers' judgment of abnormal lipase and amylase,
4. abnormal liver function tests (such as ALT, AST, serum bilirubin), which are
clinically significant, indicate liver disease, cirrhosis, or liver injury.
(alanine aminotransferase [ALT], aspartate aminotransferase [AST], alkaline
phosphatase [ALP], glutamine transpeptidase [GGT], total bilirubin) greater than
three times their respective upper limit of normal (ULN).
5. There is a history or evidence of renal dysfunction, manifested as clinically
significant creatinine or urinary composition abnormalities (such as tubular
type), or eGFR<60 ml/min/1.73m2
6. Urinary tract obstruction or difficulty in emptying urine during screening period
- Individuals with any form of medical/implant intolerance, including pacemakers, metal
plates, or magnetic resonance imaging (MRI)
- Individuals who have tested positive for human immunodeficiency virus (HIV)
antibodies, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies,
or syphilis (results within six months are exempt from testing)
- Smokers who smoke more than 10 cigarettes or an equivalent amount of tobacco per day
cannot stop smoking during the trial period
- There is a history of drug or alcohol abuse within the 12 months prior to the trial,
or evidence of abuse is found during laboratory testing during screening evaluation
- During screening, lying blood pressure (after resting for 5 minutes) exceeds the range
of 90-140mm Hg (including 90140) in systolic blood pressure, 50-90 mmHg (including 50,
90) in diastolic blood pressure, or heart rate (HR) exceeds the range of 50 bpm to 100
bpm (including 50100) in heart rate (HR)
- Tumor patients
- Participants are not suitable for the experiment
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